Prostate CancerNCT05224869
Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer
A study testing Medical Device Usage and Evaluation, CT simulation and Stereotactic body radiation therapy in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Medical Device Usage and Evaluation, CT simulation and Stereotactic body radiation therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 29 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/biopsy confirmed adenocarcinoma of prostate within 1 year of registration
- Disease confined to the prostate. Prostate volume must be <150cc confirmed by pelvic CT (with or without contrast) or pelvic/prostate MRI (with or without contrast) +/- ultrasound, within 8 months of signing research consent
- Age >18
- Patients deemed medically suitable to undergo rectal spacer placement, external beam radiotherapy and brachytherapy at the discretion of the radiation oncologist, urologist, medical oncologist and/or internist.
- ECOG score of 0-2.
- One or more of the following risk factors for intermediate risk prostate cancer; T2b or T2c clinical stage, GS 7 (either 3+4 or 4+3), PSA 10-20.
- Ability to understand and the willingness to sign a written informed consent.
- PSA result within 6 months of simulation
Who cannot join
- Patients with disease not confined to the prostate based on imaging, biopsy, or clinical exam
- Patients with a prostate size > 100 cc based on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound measurements
- Patients who have undergone previous rectal, bowel, bladder, or prostate surgeries in the past
- Patients with previous treatments for their prostate cancer or that are currently receiving any other experimental therapies
- Patients who have undergone prior pelvic radiotherapy
- Patients with high risk prostate cancer that have any of the following risk factors; GS >= 8, PSA > 20, clinical or imaging stage T3a or higher
- Patients receiving antiandrogen therapy (ADT)
- Patients with any prior active or treated genitourinary malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Randomized Phase II Study of the Reduction in Rectal V100 With the Use of Rectal Spacer Hydrogel in the Management of Intermediate Risk Prostate Cancer Treated With Combined Modality Radiation Therapy
This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It stays in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it may help spare the rectum from receiving radiation during standard of care stereotactic body radiation therapy and brachytherapy treatment.
Read the detailed description
The purpose of this research study is to observe the effects of using an FDA-approved rectal spacer device known as the SpaceOAR Hydrogel, which is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It will stay in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it will help spare the rectum from receiving radiation during the standard of care stereotactic body radiation treatment participant will be receiving, along with the brachytherapy treatment. The hydrogel rectal spacer has been shown to be very safe and effective at reducing radiation dose to the rectum during external radiation treatments, but has not been well-studied when using a combination of Stereotactic Body Radiation Therapy (SBRT) and brachytherapy. The goal of this research is to determine how effective the SpaceOAR hydrogel rectal spacer is at decreasing radiation side effects that can occur in the rectum, which can include discomfort or bleeding. The researchers also want to see how the use of this device affects the doctor's ability to perform the brachytherapy implant safely and effectively.
- Conditions
- Prostate Cancer
- Being tested
- Medical Device Usage and Evaluation, CT simulation, Stereotactic body radiation therapy, Brachytherapy, Post-implant dosimetry scan
- Keywords
- Prostate, Cancer, Brachytherapy, Radioactive Seed implant, Rectal Spacer, SpaceOAR
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Usage and EvaluationDevice
Also called Hydrogel rectal spacer, SpaceOAR Hydrogel
Undergo hydrogel rectal spacer placement
CT simulationProcedure or surgery
CT simulation of radiation treatment planning 2-7 days after hydrogel placement
Stereotactic body radiation therapyProcedure or surgery
Also called SBRT
SBRT in 5 fractions over 1 week, 7 days after CT simulation
BrachytherapyRadiation
one month after completing SBRT
Post-implant dosimetry scanProcedure or surgery
one month after brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with prostate cancer | Experimental | Patients undergo hydrogel rectal spacer placement on day 1. Within 2 weeks (+/-1 week) after Rectal Spacer placement, patients will be scheduled for CT simulation for external beam treatment planning. Patients will begin the SBRT of 24Gy in 5 fractions within 2 weeks (+/-1 week) from the simulation date. Within 4 weeks (+/-1 week) of last day of SBRT, patients undergo brachytherapy. Patient will return for post-implant CT-based dosimetry analysis 4 weeks (+/- 1 week) post brachytherapy, Receives: Device: Medical Device Usage and Evaluation; Procedure: CT simulation; Procedure: Stereotactic body radiation therapy; Radiation: Brachytherapy; Procedure: Post-implant dosimetry scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants that achieve V100rectum < 0.75 cc
Volume of the rectum receiving at least 100% of the prescribed dose (V100rectum) < 0.75 cc rate will be estimated as the proportion of patients that achieve V100rectum < 0.75 cc at the post-implant dosimetry computed tomography scan 1 month following brachytherapy along with a corresponding two-sided 90% confidence interval using the methods and software introduced by Koyama and Chen which accounts for the group sequential nature of the design
Measured: At 1 month post-brachytherapy (at about 2 months)
Secondary outcomes (7)
D90prostate
Radiation dose covering 90% of the prostate (D90prostate)
Measured: At the time of post-implant dosimetry (at about 3 months)
V150prostate
Volume of the prostate receiving at least 150% of the prescribed dose (V150prostate)
Measured: At the time of post-implant dosimetry (at about 3 months)
Number of participants with anatomic distortions
Degree of anatomic distortions present while using the brachytherapy template assessed by the physician. Will be summarized as N (%) of patients where varying levels of anatomic distortion was present: No Pubic Arch interference, =< 5 mm interference and > 5mm interference.
Measured: At the time of the brachytherapy implant (at about 2 months)
Number of participants with radiographic distortion
Degree of ultrasound distortion present Assessed by the physician. Will be summarized as N (%) of patients where varying levels of radiographic distortion was present: No Distortion, Mild Distortion, and Severe Distortion.
Measured: At the time of the brachytherapy implant (at about 2 months)
Change in International Prostate Symptom Score (IPSS)
The IPSS endpoint is based on a questionnaire made up of eight items, seven of which measure symptom severity and one which assesses quality of life. The symptom severity items include: feeling of incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each of which is rated from 0 (''not at all'') to 5 (''almost always''). The IPSS total score ranges from 0-35, with a higher score representing greater severity of symptoms, which can be further categorized into mild (0-7), moderate (8-19) and severe (20-35) symptom severity.
Measured: Baseline and up to 2 years post-treatment
Change in Sexual Health Index in Men (SHIM)
The SHIM endpoint is based on a questionnaire made up of five questions each of which is rated from 1 (''very low'') to 5 (''very high''). The SHIM total score (calculated by summing the individual rating for each question) ranges from 5-25, with a lower score representing greater severity of symptoms which can be further categorized into severe erectile dysfunction (ED) (5-7), moderate ED (8-11), mild to moderate ED (12-16), mild ED (17-21) and no ED (22-25).
Measured: Baseline and up to 2 years post-treatment
Change in Expanded Prostate Cancer Index Composite (EPIC)
The EPIC endpoint is based on a questionnaire made up of 50 questions assessing the disease specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supports dividing the Urinary Domain Summary Score into two distinct Incontinence and Irritative/Obstructive subscales (Subscales scored from 0-100). In addition, each Domain Summary Score has measurable Function Subscale and Bother Subscale components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
Measured: Baseline and up to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start31 Aug 2021
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Why it stopped: Was not meeting target enrollment; other treatment options precluded completing study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Stock, Icahn School of Medicine at Mount Sinai
- Investigators
- Richard Stock, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224869
- Sponsor's protocol ID
- GCO 21-0603
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Sharing data is not planned unless specifically requested by another institution.
Publications
Nehlsen AD, Sindhu KK, Moshier E, Sfakianos JP, Stock RG. The impact of a rectal hydrogel spacer on dosimetric and toxicity outcomes among patients undergoing combination therapy with external beam radiotherapy and low-dose-rate brachytherapy. Brachytherapy. 2021 Mar-Apr;20(2):296-301. doi: 10.1016/j.brachy.2020.09.018. Epub 2020 Nov 13.
PubMed 33199175
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Phase II Study of the Reduction in Rectal V100 With the Use of Rectal Spacer Hydrogel in the Management of Intermediate Risk Prostate Cancer Treated With Combined Modality Radiation Therapy
- ClinicalTrials.gov ID
- NCT05224869
- Acronym / sponsor ID
- GCO 21-0603
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Brachytherapy, Radioactive Seed implant, Rectal Spacer, SpaceOAR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Was not meeting target enrollment; other treatment options precluded completing study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the effect of rectal spacer hydrogel before radiation therapy in reducing radiation dose to the rectum in patients with prostate cancer. Rectal spacer hydrogen is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It stays in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it may help spare the rectum from receiving radiation during standard of care stereotactic body radiation therapy and brachytherapy treatment.
Detailed description
The purpose of this research study is to observe the effects of using an FDA-approved rectal spacer device known as the SpaceOAR Hydrogel, which is a soft gel material used to create a space between the rectum and prostate during radiation treatment. The rectal spacer gel is made up of 90% water and 10% polyethylene glycol and is injected as a liquid through a needle inserted between the rectum and prostate. It will stay in place for about 3 months and is naturally absorbed into the body and removed through urine in about 6 months. By pushing the prostate further from the rectum with the hydrogel, it will help spare the rectum from receiving radiation during the standard of care stereotactic body radiation treatment participant will be receiving, along with the brachytherapy treatment. The hydrogel rectal spacer has been shown to be very safe and effective at reducing radiation dose to the rectum during external radiation treatments, but has not been well-studied when using a combination of Stereotactic Body Radiation Therapy (SBRT) and brachytherapy. The goal of this research is to determine how effective the SpaceOAR hydrogel rectal spacer is at decreasing radiation side effects that can occur in the rectum, which can include discomfort or bleeding. The researchers also want to see how the use of this device affects the doctor's ability to perform the brachytherapy implant safely and effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prostate cancer | Experimental | Device: Medical Device Usage and Evaluation, Procedure: CT simulation, Procedure: Stereotactic body radiation therapy, Radiation: Brachytherapy, Procedure: Post-implant dosimetry scanPatients undergo hydrogel rectal spacer placement on day 1. Within 2 weeks (+/-1 week) after Rectal Spacer placement, patients will be scheduled for CT simulation for external beam treatment planning. Patients will begin the SBRT of 24Gy in 5 fractions within 2 weeks (+/-1 week) from the simulation date. Within 4 weeks (+/-1 week) of last day of SBRT, patients undergo brachytherapy. Patient will return for post-implant CT-based dosimetry analysis 4 weeks (+/- 1 week) post brachytherapy, |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically/biopsy confirmed adenocarcinoma of prostate within 1 year of registration
- Disease confined to the prostate. Prostate volume must be <150cc confirmed by pelvic CT (with or without contrast) or pelvic/prostate MRI (with or without contrast) +/- ultrasound, within 8 months of signing research consent
- Age >18
- Patients deemed medically suitable to undergo rectal spacer placement, external beam radiotherapy and brachytherapy at the discretion of the radiation oncologist, urologist, medical oncologist and/or internist.
- ECOG score of 0-2.
Key exclusion criteria (8 listed)
- Patients with disease not confined to the prostate based on imaging, biopsy, or clinical exam
- Patients with a prostate size > 100 cc based on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound measurements
- Patients who have undergone previous rectal, bowel, bladder, or prostate surgeries in the past
- Patients with previous treatments for their prostate cancer or that are currently receiving any other experimental therapies
- Patients who have undergone prior pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Usage and EvaluationAlso: Hydrogel rectal spacer, SpaceOAR HydrogelUndergo hydrogel rectal spacer placement | Device | Patients with prostate cancer |
| CT simulationCT simulation of radiation treatment planning 2-7 days after hydrogel placement | Procedure or surgery | Patients with prostate cancer |
| Stereotactic body radiation therapyAlso: SBRTSBRT in 5 fractions over 1 week, 7 days after CT simulation | Procedure or surgery | Patients with prostate cancer |
| Brachytherapyone month after completing SBRT | Radiation | Patients with prostate cancer |
| Post-implant dosimetry scanone month after brachytherapy | Procedure or surgery | Patients with prostate cancer |
Primary outcome
The proportion of participants that achieve V100rectum < 0.75 cc
Time frame: At 1 month post-brachytherapy (at about 2 months)
Volume of the rectum receiving at least 100% of the prescribed dose (V100rectum) < 0.75 cc rate will be estimated as the proportion of patients that achieve V100rectum < 0.75 cc at the post-implant dosimetry computed tomography scan 1 month following brachytherapy along with a corresponding two-sided 90% confidence interval using the methods and software introduced by Koyama and Chen which accounts for the group sequential nature of the design
7 secondary outcomes
D90prostate
Time frame: At the time of post-implant dosimetry (at about 3 months)
V150prostate
Time frame: At the time of post-implant dosimetry (at about 3 months)
Number of participants with anatomic distortions
Time frame: At the time of the brachytherapy implant (at about 2 months)
Number of participants with radiographic distortion
Time frame: At the time of the brachytherapy implant (at about 2 months)
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline and up to 2 years post-treatment
Change in Sexual Health Index in Men (SHIM)
Time frame: Baseline and up to 2 years post-treatment
Change in Expanded Prostate Cancer Index Composite (EPIC)
Time frame: Baseline and up to 2 years post-treatment
Results and safety
The study was stopped early (reason given: Was not meeting target enrollment; other treatment options precluded completing study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 33199175Nehlsen AD, Sindhu KK, Moshier E, Sfakianos JP, Stock RG. The impact of a rectal hydrogel spacer on dosimetric and toxicity outcomes among patients undergoing combination therapy with external beam radiotherapy and low-dose-rate brachytherapy. Brachytherapy. 2021 Mar-Apr;20(2):296-301. doi: 10.1016/j.brachy.2020.09.018. Epub 2020 Nov 13.
- Individual participant dataSharing planned: No. Sharing data is not planned unless specifically requested by another institution.
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RecruitingPhase 2
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Stock principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device Usage and Evaluation, CT simulation and Stereotactic body radiation therapy in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Was not meeting target enrollment; other treatment options precluded completing study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants that achieve V100rectum < 0.75 cc (time frame: At 1 month post-brachytherapy (at about 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.